Nowadays the necessity for providing a breast reconstruction after mastectomy is accepted.
The current surgery for breast reconstruction after mastectomy is divided into two techniques: one in two stages and one in a single stage.
For the two stage technique mastectomy, the surgeon prepares a submuscular pocket creating a space between the chest wall and the pectoralis major muscle, which is low-cut and etched down to the superficial fascia at its lower pole and medial to the fourth space intercostal.
It then proceeds laterally along the serratus muscle fascia.
An appropriate tissue expander is then placed inside and closes the pocket in such a way as to contain the whole device inside.
In the following days there is progressive inflation until the desired expansion has been achieved.
The expander is then removed no earlier than 4/6 months during a second operation that will include the removal of the expander and placement of the final prosthesis.
The single stage reconstruction technique involves the placement, after mastectomy, of a breast implant in a submuscular pocket, created with the technique described previously.
The breast implant is subsequently inserted into the submuscular cavity and is covered at its lower pole with a network of biomaterial thereby avoiding the need for muscle expansion.
The results of the two techniques are used for breasts of small and medium dimensions.
Large breasts currently represent an indication for reconstruction in two stages.
The results of the two techniques are similar from a physiological point of view, since, in any case, there is the dissection and resection of the pectoralis major muscle that entails its dislocation and therefore a substantial loss of movement.
With regard to the physiology of the pectoralis major muscle it can be stated that in case of disconnection, the movements that may be deficient are the anteposition and the arm flexion, internal rotation and adduction.
Moreover, considering the movement of the shoulder and upper limb, we must consider the synergistic action of various finely modulated muscle groups; also a modest quantity of weakening of these can alter the pace shoulder joint with an impact on the normal activities of daily life.
In fact, the pectoralis major muscle is located in the chest, anteriorly, between the medial part of the clavicle, sternum and cartilage of the first 6/7 coastline, the external aponeurosis dell'obliguo (medially) and the ridge under Annex E, Table I.
The muscle is divided into two parts: the head and the sternocostal head clavicular, which differ in their effects on the motility of the shoulder and upper limb.
The clavicular head flexes the arm and moves it forwards toward the contralateral shoulder and rotates it internally.
The sternocostal head depresses the shoulder, adducts the arm toward the contralateral iliac crest and rotates it internally.
The actions of this muscle can combine differently, between them and with the movements generated by many other muscles acting on the shoulder, allow normal movement.
The shoulder, both anatomical and functional, is an extremely complex mechanism that has a very large motor ability.
This entails the need to dispose of synergies of activation, regulation and balance of the various muscle components in relation to the control of the multiple parameters (direction, distance, strength, speed, endurance) to produce a movement qualitatively “normal”, that is precise, smooth and suitable for the motor task required.
The movements which may be deficit, in the case of partial lesion of the pectoralis major, are the anteposition and the arm flexion, internal rotation and adduction, in a manner which is evident to a greater or lesser degree, in relation to the position and to the extent of the lesion.
In addition, with regard to the range of movement of the shoulder and upper limb, we must consider the synergistic action of various finely modulated muscle groups, the weakening of also a modest amount of which can alter the pace shoulder joint with repercussions on everyday life.
The state of the art is a prosthesis to maintain the position and shape of an organ (patent No. 2746298). The advantages of this new medical device when compared to the one above described are several:
a) the U.S. Pat. No. 2,746,298 can be used only over the organ of the breast still present in the human body, but cannot be used on a prosthesis when it is inserted after the removal of the mammary gland, following breast cancer or preventive treatment for breast cancer rather the invention is used to cocoon the breast implant when placing it over the pectoralis major muscle, once the mammary gland is removed.
b) the U.S. Pat. No. 2,746,298 is formed from two pieces which don't completely envelop the organ (breast), but it is only rested against it, with the only function being to “pull up” the breast (breast lift). The invention instead envelops an entire prosthesis and allows it to be attached over and in contact with the pectoralis major muscle during breast reconstruction after removal of the mammary gland.
c) the U.S. Pat. No. 2,746,298 is fixed on both sides (above and below): above (collarbone) and below (to the chest wall) precisely in order to maintain the new positioning of the breast in a fixed position. The invention instead is fixed exclusively on the pectoralis major muscle, leaving the lower pole free which allows the placement of the implant not to be fixed.
d) the function of the U.S. Pat. No. 274,698 is to replace a breast affected by ptosis in the position that it had been before the ptosis. It's a kind of internal bra that allows the organ which is still intact, healthy and not affected by cancer to be pulled up. The new feature of the invention is to completely wrap a breast prosthesis, not a gland, after the removal of the mammary gland, allowing the subcutaneous application in the cavity produced by the removal, rather than under the muscle.
Another patent (PCT/US2012/027975) speaks about systems and methods for mastopexy.
Patent n. US 2002/0042658 has a form and a function which is completely different.
a) Geometrically, in fact the diversity of forms emerges; the invention serves to wrap a prosthesis, while the cited patent (US 2002/0042658) serves to cover a defect in the abdominal wall.
b) the patent US 2002/0042658 has a central portion which is reinforced precisely in order to withstand the tension of the abdominal wall; the invention does not have portions reinforced due to not having to bear pressure having as a purpose to wrapping of a breast prosthesis.
c) the cited patent US 2002/0042658 is folded to be inserted within a tube inside the human abdomen and then re-opened to cover the defect of the abdominal wall. The invention, instead wraps a breast prosthesis and is then inserted already formed three-dimensionally inside the body.
d) the cited patent US 2002/0042658 has hooks for anchoring to the abdomen. The invention has no hooks, being only sutured to the pectoralis major muscle.
In the state of art there is also another patent (n. WO 2012/122215).
Patent no. WO 2012/122215 is a different device that does not solve many problems that, instead, the invention overcomes:
a) the form of the patent n. WO 2012/122215 has a main body with the strap. The shape and size “is sized to span substantially a portion of the lower pole of the breast and not cover the nipple areolar complex” (0023). The invention rather is an irregular shape devoid of the strap with a size and shape adapted to cover the entire prosthesis.
b) the patent n. WO 2012/122215 relates to a device that is a support in the lower pole breast integrates, in order to pull it out. The invention, however presupposes the removal of the mammary gland and the total coverage of the prosthesis, which is then inserted into the cavity created by the removal of the gland with the tumor. The invention then, does not include any anchor in the lower pole, which, other than as described in patent no. WO 2012/122215, leaves the lower pole free, being the invention sutured only to the pectoralis major muscle.
c) The patent no. WO 2012/122215 performs the function of lift up the breast to solve or prevent a ptosis. The invention instead performs the function of allowing the operating technique “muscle sparing”, allowing the insertion of the prosthesis over the pectoralis major muscle.
Another patent is regarding three dimensional hernia mesh (EP 2524670A1).
To clarify the obvious differences, they are detailed below.
a) FIG. 17 of the patent EP 2524670A1 illustrates the folding plan for the implant. While the implant is folded into a three dimensional structure, it is folded into a vertical alignment made up of at least two layers superimposed by glueing or heat setting and wing bars. The structure of the patent n. EP 2524670A1 is a T profile or H profile while the invention has no layers, it envelops a breast prosthesis and sutured around a prosthesis without the use of thermofixing and/or glueing and has no wing bars.
b) The patent EP 2524670A1 is used for closing wounds and sealing defects in the inner and outer abdominal wall and strengthening it. The invention however is used to completely wrap a breast prosthesis during reconstruction after the removal of the mammary gland and is attached to the pectoralis major muscle.
c) Patent EP 2524670A1 is designed to be flexible so that turning is easily possible. It is characterized by outer edge which is upturned and can be fixed by glueing or heat setting or closed with a silicon layer. The invention is inserted preprepared and fixed into position. It is not flexible, does not have an outer edge and no silicone is used.